Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

Official Title

A Phase 3 Randomized, Double-blind, Multicentre, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor


This is a randomized, double-blind, multicentre, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Overall Survival (OS)
  • Progression Free Survival (PFS)
  • Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-C30 questionnaire
  • Immunogenicity of monalizumab
  • Association of NK cell-related protein markers with efficacy endpoints including OS, PFS, and ORR
  • Assessment of Adverse Events (AE)
  • Objective Response Rate (ORR)
  • Duration of Response (DoR)
  • Disease-related symptoms, functioning and quality of life measured by EORTC QLQ-H&N35 questionnaire
  • Pharmacokinetics (PK) analysis of monalizumab
Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Patients in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All patients will be followed for survival after progression is confirmed.

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Canadian Cancer Society

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